Based in Croatia, the company utilises a large network of associates in countries such as Slovenia, Bosnia, Romania, Bulgaria, Turkey, Slovakia, Czech Republic, the US, and Brazil, as well as Middle East and North Africa (MENA) and Commonwealth of Independent States (CIS) countries.

The firm helps clients keep up-to-date in the rapidly changing, high-demand pharmaceutical markets. Its motto is ‘Give us your trust and we will exceed your expectations!’

The company also offers full lifecycle maintenance for veterinary drugs, generics, biologicals, and biosimilars, helping clients to complete initial registration, renewals, transfers of registration, and line extensions.

PharmaVigil is experienced in preparing medical device companies for Conformité Européene (CE) registration, including the writing and collating of required documents, planning regulatory strategy, and supplying translations. This service is available for Class I, Class II, and Class II medical devices, including in-vitro diagnostics (IVD).

The firm also helps ensure that documentation and labelling of feed additives, supplements, biocides, cosmetics, and food products meet the requirements of current EU directives as preparation for registering to the EC’s Cosmetic Product Nutrition Portal (CPNP).

Pharmacovigilance systems and audits for healthcare manufacturers

The company processes adverse events (AE) and suspected unexpected serious adverse events (SUSARs) in the EudraVigilance environment, as well as provides support during health inspections, performs signal detection activities, and makes weekly literature reviews.

The firm also organises and performs good manufacturing practice (GMP) audits.

Meeting international regulatory guidelines

PharmaVigil helps arge and small businesses maintain products already on the market by keeping them up-to-date with regulatory changes.

Its electric common technical document (eCTD) tool provides a range of international templates for eCTD submissions, enabling a quick and effective handling of pharmaceutical documentation such as clinical and electronic drug master files (e-DMF).

This robust and reliable software was made in collaboration with partner Freyr Inc.

Phamacoeconomics reimbursement and study design

Language solutions for medical device labelling

PharmaVigil’s language solutions enable clients to clearly convey critical information to patients, healthcare professionals, and stake holders. The company has a dedicated network of skilled translators with strong medical, technical, and scientific backgrounds for many language combinations.